Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)

This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Netherlands Cancer Instiute

Amsterdam, 1066 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
No chemotherapy or surgery prior to inclusion
No distant metastatic spread at the time of inclusion
Age ≥ 18 years
WHO performance status 0 or 1
Signed written informed consent

Exclusion criteria

Patients with previously radiation treatment in the head and neck region, for any reason
Patients with previous neck dissection
Patients with recurrent or second primary tumor in the head and neck region
Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
Pregnancy or no active contraception for pre-menopausal women
Known hypersensitivity to iodine or nanocolloid injection
Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow up schedules

Treatment and study plan

radiation in Squamous Head and Neck Cancer

Radiation

Primary outcomes

Feasibility and safety of single side radiation therapy measured by physical examination and toxicity measurement by CTCAE 4.03 at 12 weeks

Time frame: 12 weeks

mapping of sentinel lymph node drainage to indentify groups at low risk of the probability of contra regionale failure is to be estimated to be 2% at 2 years. A recurrrence rate of >15% will be assumed unacceptable

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Mapping of Sentinel Lymph Node Drainage Using SPECT to Tailor Highly-Selective Elective Nodal Irradiation in Node-Negative Neck of Patients With Head and Neck Cancer (SUSPECT)

Acronym: SUSPECT

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Oct 9, 2015
Registry last updated: Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed